Prescription medicine
Bromocriptine Brand names: Cycloset; first approved as Parlodel
Bromocriptine (Parlodel) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.61 per bromocriptine 2.5 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $5.26 per Cycloset 0.8 mg tablet.
- Generic listed
Check it at the source: the bromocriptine FDA label on DailyMed (effective July 27, 2026, ANI Pharmaceuticals, Inc.); the NDA 17962 record on Drugs@FDA; every bromocriptine label on DailyMed.
Highlights of the record
FDA label of July 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults (1.1) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older (1.2).
Forms and strengths
- 0.8 mg
- 2.5 mg
- 5 mg
Tablet; capsule.
On the market
- Earliest approval on file
- June 28, 1978 Parlodel, Esjay Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first January 13, 1998; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 6 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- April 30, 2032 Cycloset tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.61 per tablet Bromocriptine 2.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest October 23, 2025
- FAERS reports
- 646 through July 30, 2026
What is bromocriptine used for?
From the label: indications and usageBromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults (1.1) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older (1.2). Acromegaly in adults (1.3). Signs and symptoms of idiopathic Parkinson’s disease or postencephalitic parkinsonism in adults (1.4). […]
Conditions named in the indications of bromocriptine's FDA labels, with every medicine labeled for each:
From other bromocriptine labelsType 2 diabetes: CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA pharmacologic class: Ergot Derivative.
Source: FDA drug label (Bromocriptine Mesylate), ANI Pharmaceuticals, Inc., effective July 27, 2026 (SPL set 17f3a343-1782-4799-95ba-31dfe93be2cf), via openFDA; the full label on DailyMed
Is there a generic for bromocriptine (Parlodel)?
The FDA approved the first generic bromocriptine on January 13, 1998. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bromocriptine from 6 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Parlodel tablets; a patent listed only for Cycloset tablets runs to April 30, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1978 earliest approval on file
- 1998 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bromocriptine (Parlodel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.61 per Bromocriptine 2.5 mg tablet, down 9% from $1.77 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bromocriptine 2.5 mg tablet (generic)
- Cycloset 0.8 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bromocriptine 2.5 mg tablet | Generic | $1.61 per tablet | $48.28 | -9% |
| Bromocriptine 5 mg capsule | Generic | $4.12 per capsule | $123.50 | +12% |
| Cycloset 0.8 mg tablet | Brand | $5.26 per tablet | $157.69 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bromocriptine been recalled?
The FDA's Enforcement Report lists 5 recalls naming bromocriptine since 2013: 0 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 23, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. |
| May 9, 2016 | Class II | Zydus Pharmaceuticals USA Inc | Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 200 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bromocriptine label say about other medicines?
The bromocriptine label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name bromocriptine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chloramphenicol | drug interactions | Therefore, CYCLOSET may increase the unbound fraction of other concomitantly used highly protein-bound therapies (e.g., salicylates, sulfonamides, chloramphenicol and probenecid), which may alter their effectiveness and risk for side effects. |
| Clozapine | warnings and precautions | Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (e.g., clozapine, olanzapine, ziprasidone), may reduce the effectiveness of CYCLOSET, and CYCLOSET may reduce the effectiveness of these agents. |
| Erythromycin | drug interactions | CYCLOSET dose should not exceed 1.6 mg once daily during concomitant use of a moderate CYP3A4 inhibitor (e.g., erythromycin). |
| Levodopa | warnings and precautions | Reactions and Risks in Patients with Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism Mental Disturbances and Psychotic Symptoms Bromocriptine mesylate administered alone or concomitantly with levodopa may cause hallucinations (visual or auditory). |
| Metoclopramide | drug interactions | Concomitant use of dopamine receptor antagonists, such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes), or metoclopramide may diminish the effectiveness of CYCLOSET, and CYCLOSET may diminish the effectiveness of these other therapies. |
| Olanzapine | warnings and precautions | Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (e.g., clozapine, olanzapine, ziprasidone), may reduce the effectiveness of CYCLOSET, and CYCLOSET may reduce the effectiveness of these agents. |
| Probenecid | drug interactions | Therefore, CYCLOSET may increase the unbound fraction of other concomitantly used highly protein-bound therapies (e.g., salicylates, sulfonamides, chloramphenicol and probenecid), which may alter their effectiveness and risk for side effects. |
| Sumatriptan | drug interactions | Also, there are limited clinical trial data supporting the safety of selective 5-hydroxytryptamine 1B (5-HT 1B ) agonists (e.g., sumatriptan) used concurrently with CYCLOSET, and the concomitant use of these agents with CYCLOSET should be avoided. |
| Ziprasidone | warnings and precautions | Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (e.g., clozapine, olanzapine, ziprasidone), may reduce the effectiveness of CYCLOSET, and CYCLOSET may reduce the effectiveness of these agents. |
Other labels that name bromocriptine
Source: FDA drug label (Bromocriptine Mesylate), ANI Pharmaceuticals, Inc., effective July 27, 2026 (SPL set 17f3a343-1782-4799-95ba-31dfe93be2cf), via openFDA; the full label on DailyMed
What do FAERS reports show for bromocriptine?
The FDA Adverse Event Reporting System holds 646 reports that list bromocriptine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 234 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bromocriptine?
13 other medicines are given the same way (oral) and in the same FDA class as bromocriptine or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Carbidopa and levodopa | Parkinson's disease | 33 labelers | $0.0759 per tablet 25-100 tablet | No current entry |
| Benztropine | Parkinson's disease | 19 labelers | $0.0753 per tablet 1 mg tablet | A presentation being discontinued |
| Rasagiline | Parkinson's disease | 14 labelers | $0.521 per tablet 0.5 mg tablet | No current entry |
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
Every medicine labeled for the same conditions as bromocriptine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does bromocriptine compare with medicines for the same use?
2 side-by-side pages set bromocriptine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to bromocriptine
- 13 medicines for the same use
- Other ergot derivatives
- the pharmacologic class, with prices and generics
- Bromocriptine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other